Model Number BI70002000 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A medtronic representative went to the site to test the equipment.Testing revealed that there was controller errors during the time of the issue.The positioner controller module was replaced and the system then was performing as intended.Concomitant medical products information references the main component of the system.Other relevant device(s) are: product id: bi 71000443r.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned.¿ these words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system's gantry had no motion.There was no patient present.Additional information was received that manual work-arounds were not available to move the gantry.
|
|
Manufacturer Narrative
|
H3/h6: the position motion control was returned to the manufacturer for analysis.The positioner motion control was installed into a known working test system the system did not initialized.Motion did not ready.There was a firmware mismatch.The firmware was up to date.The firmware was flushed and the system rebooted.Motion calibration passed.Motion, generator, communication and charging readied.3d and 2d images passed.The reported failure was due to a software issue.Codes b01, c10 and d02 apply to this analysis.The lot number of product id: bi71000443r was received.The lot number is: p071822077 rev.4.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|